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Low Oxygen Exposure and Weight Status

Pennington Biomedical Research Center · with National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NCT05289310

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Ages 22–65 · All sexes
Healthy volunteers
Accepted
Study type
Interventional · Not applicable
Target enrollment
60
US sites recruiting
1
Study start
May 16, 2023
Record last updated
July 16, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

The objective of the proposed double-blind, parallel-arm, randomized clinical trial is to evaluate changes in body weight and composition, assess determinants of energy balance (intake and expenditure), and measure modulators of energy balance, following 8 wk of calorie restriction (-500 kcal/d) in combination with either overnight exposure to normobaric hypoxia (8 h/night, 15% FiO2, \~2640 m) or normoxia (8 h/night, 21% FiO2), using a commercially available, in-home tent system, in adults with obesity.

Being studied: Normobaric hypoxia (NH); Normobaric normoxia (NN)

Conditions: Obesity

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria

Inclusion Criteria

  • Obese (BMI between 30-39.9 kg/m2)
  • Born at altitudes below 2,100 meters (\~7,000 feet)
  • Currently residing in Tallahassee, Florida or surrounding area
  • Completed a full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person human research activity.
  • Not taking any medication(s) that interfere with oxygen delivery/transport for 4 weeks prior to and throughout the entire study (e.g., includes sedatives, sleeping aids, tranquilizers and/or any medication that depresses ventilation, diuretics, alpha and beta blockers).
  • Willing to refrain from smoking, vaping, chewing tobacco, and dietary supplement use throughout the entire study.
  • Willing to have a hypoxic tent set-up in their home and spend 8 consecutive hours per night in the tent for 8 weeks
  • Lives with a family member, partner/spouse, or roommate who can hear and respond in the unlikely event that the blood oxygen, air oxygen, or air carbon dioxide monitoring alarm would sound.

Exclusion Criteria

  • Living in areas that are more than 1,200 m (\~4,000 feet), or have traveled to areas that are more than 1,200 m for five days or more within the last 2 months
  • Individuals who have not completed a full FDA authorized or approved COVID-19 vaccination series at least 14 days before any in-person human research activity.
  • Cardiovascular abnormalities, gastrointestinal disorders, or any condition that interferes with oxygen delivery/transport (e.g., kidney disease, cardiovascular disease, etc.)
  • Oxygen saturation \< 95% while awake or oxygen saturation dips below 88% for a total of ≥ 10 min overnight in normoxic conditions
  • Evidence of apnea or other sleeping disorders
  • Evidence of prior high-altitude pulmonary edema (HAPE) or high-altitude cerebral edema (HACE) diagnosis
  • Diagnosis or family history of sickle cell anemia/trait
  • Hematocrit \<42% for males, \<36% for females
  • Hemoglobin \<13 g/dL for males, \<12 g/dL for females
  • Blood donation within 8 weeks of beginning the study
  • Present condition of alcoholism, anabolic steroids, or other substance abuse issues
  • Women who are pregnant, lactating, planning to become pregnant, or who have had an irregular menstrual cycle in the past 6 mo.
  • Weight gain or loss > 10% of body weight during the past 6 months
  • Adults unable to consent

Recruiting US locations

  • Pennington Biomedical Research Center

    Baton Rouge, LA 70808

    Site contact: Claire E Berryman, PhD,RD · claire.berryman@pbrc.edu

Study contacts (from the official record)

  • Claire E. Berryman, PhD, RD · 3042161050 · claire.berryman@pbrc.edu
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Low Oxygen Exposure and Weight Status (NCT05289310) | Bored Studies